ECHA flags 28 substances for evaluation over next three years

Chemicals | By SCOTT STEPHENS, MPA

Mar. 20, 2024

This week, ECHA finalized its annual update to the Community Rolling Action Plan (CoRAP), listing 28 substances that will be assessed under the REACH Regulation’s substance evaluation procedure during the 2024-2026 period. Ten substances have been prioritized for evaluation this year, including dioctyltin oxide, tetrasodium glutamate diacetate, and tribromophenol.

What is CoRAP?

  • The Community Rolling Action Plan (CoRAP) belongs to the “E” in REACH (registration, evaluation, authorization, and restriction of chemicals; Regulation (EC) 1907/2006). Laid out in Chapter 2 of Title VI, CoRAP is part of REACH’s substance evaluation procedure (as opposed to dossier evaluation) to determine if certain chemicals pose a risk to people or the environment. Member-state competent authorities and the European Chemicals Agency (ECHA) must select and prioritize substances annually for evaluation over a three-year period on an ongoing basis. Individual member states are assigned to carry out the evaluations of the listed substances. Those considered of highest priority are evaluated during the current year, while lower priority substances are scheduled for evaluation in the subsequent second and third years of the three-year period.
  • Substances are identified and prioritized for CoRAP using a risk-based approach. Selection is based on three criteria listed in Article 44(1): (1) information available on the chemical’s known or suspected intrinsic hazards; (2) exposure information, including use applications, use settings and conditions, and typical users; and (3) the tonnage band in which the chemical is registered under REACH. Substances that are suspected of exhibiting more hazards of concern – like persistence, bioaccumulation, and toxicity (PBTs), or carcinogenicity, mutagenicity, and toxicity to reproduction (CMRs), or respiratory sensitization – which also have a wider and more dispersive use and higher probability of exposure, are more likely to be selected for CoRAP listing.
  • Obtaining more information is key to determining whether the CoRAP-listed substances truly pose risks that may need to be further managed under the EU’s regulatory risk management (RRM) framework. This is where industry gets involved: the member state assigned to evaluate substances will frequently request more information from registrants, often extending beyond the scope of information required for registration under REACH.
  • Being listed in CoRAP does not necessarily mean a substance will eventually be subject to further RRM measures. Rather, the CoRAP process is focused on clarifying a concern about substances posing a risk. This may be confirmed or dismissed through substance evaluation.

ECHA publishes the 2024 update to CoRAP

  • On March 19, ECHA published the list of CoRAP substances to be evaluated during 2024, 2025 and 2026. This follows adoption of the draft list by the agency’s Member State Committee (MSC) on February 13. Below is the final list, which, when compared to CoRAP for 2023-2025, encompasses 11 new substances in addition to the 17 substances that were already present on the list (for a total of 28).
  • The first 10 substances listed below have been prioritized for evaluation in 2024, including four substances that the Danish competent authority will likely evaluate as a group, given their apparent structural similarity.
  • Evaluation of the next 13 entries is scheduled for 2025, including two groups of substances likely to be addressed in joint evaluations, also because of their apparent structural similarity. Spain and France respectively have been tapped to evaluate these groups, represented by the following identifiers: (1) EC Nos. 701-246-8, 701-463-8; and (2) CAS RNs 99-62-7, 100-18-5, and EC No. 905-459-9.
  • The five remaining substances on the list are scheduled for 2026 and have been assigned to France and the Netherlands.
  • Finally, one substance – tris[2-chloro-1-(chloromethyl)ethyl] phosphate – whose evaluation Germany was assigned to conduct in 2024, has been withdrawn. This withdrawal comes after the authorities determined that the substance must first undergo a compliance check under dossier evaluation. ECHA states that if concerns about related risks persist following this compliance check, the substance may be placed back on the CoRAP list.
Year Year in previous CoRAP Evaluating member state CAS RN Substance name Initial grounds for concern Source
2024 Spain 107-52-8 tetradecamethylhexasiloxane

suspected PBT/very persistent, very bioaccumulative (vPvB),

consumer use,

exposure of environment,

wide dispersive use

New
2024 Denmark 1745-89-7 4,4′-isopropylidenebis[2-allylphenol]

suspected reproductive toxicant (R),

potential endocrine disruptor,

exposure of environment,

exposure of workers,

wide dispersive use

New
2024

5613-46-7

4,4′-isopropylidenedi-2,6-xylol

New
2024

19224-29-4

2,2′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bisethyl diacetate

New
2024

27689-12-9

(1-methylethylidene)bis(4,1-phenyleneoxy-3,1-propanediyl) bismethacrylate

New
2024 France

51981-21-6

Tetrasodium N,N-bis(carboxylatomethyl)-L- glutamate

suspected carcinogen (C),

consumer use,

exposure of environment,

exposure of workers,

high (aggregated) tonnage,

wide dispersive use

New
2024 France

118-79-6

2,4,6-tribromophenol

suspected R,

potential endocrine disruptor,

suspected PBT/vPvB,

other hazard-based concern,

exposure of workers,

exposure of environment

New
2024 Sweden

10081-67-1

4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline

suspected PBT/vPvB,

consumer use,

exposure of environment,

exposure of sensitive populations,

exposure of workers,

high (aggregated) tonnage,

wide dispersive use

New
2024 2024 Ireland/ Portugal

22174-70-5

3,3′-[methylenebis(oxymethylene)]bisheptane

suspected R,

suspected PBT,

wide dispersive use,

consumer use,

exposure of workers,

exposure of environment

Already in CoRAP
2024 2024 Austria

870-08-6

Dioctyltin oxide

suspected R,

potential endocrine disruptor,

suspected PBT/vPvB,

wide dispersive use,

exposure of environment,

consumer use,

exposure of workers,

high risk characterization ratio (RCR),

high (aggregated) tonnage

Already in CoRAP
2025 Netherlands

n.a.
(EC No. 947-768-1)

Reaction product of graphite, acid-treated and potassium permanganate

suspected mutagen (M),

other hazard-based concern,

exposure of workers,

wide dispersive use

New
2025 Spain

n.a.
(EC No. 701-246-8)

Oligomerization products of beta-pinene

suspected PBT/vPvB,

consumer use,

exposure of environment,

wide dispersive use

New
2025 Spain

n.a.
(EC No. 701-463-8)

Oligomerization products of alpha-pinene and beta-pinene

suspected PBT/vPvB,

consumer use,

exposure of environment,

wide dispersive use

New
2025 2024 France

99-62-7

1,3-diisopropylbenzene

suspected R,

suspected PBT/vPvB,

exposure of workers

Already in CoRAP
2025 2024 France

100-18-5

1,4-diisopropylbenzene

suspected R,

suspected PBT/vPvB,

other hazard-based concern,

exposure of environment,

exposure of workers

Already in CoRAP
2025 2024 Italy

2162-74-5

Bis(2,6-diisopropylphenyl) carbodiimide

suspected PBT,

wide dispersive use,

exposure of workers

Already in CoRAP
2025 2024 Netherlands

192268-65-8

A mixture of: triphenylthiophosphate and tertiary butylated phenyl derivatives

suspected PBT/vPvB Already in CoRAP
2025 2024 France

n.a.
(EC No. 905-459-9)

Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene

suspected R,

suspected PBT/vPvB,

other hazard-based concern,

exposure of workers,

exposure of environment,

high aggregated tonnage

Already in CoRAP
2025 2024 France

100-52-7

Benzaldehyde

suspected M,

wide dispersive use,

consumer use,

exposure of workers

Already in CoRAP
2025 2025 France

25584-83-2

Acrylic acid, monoester with propane-1,2-diol

suspected C,

suspected M,

suspected sensitizer,

wide dispersive use,

exposure of workers,

high RCR,

high (aggregated) tonnage,

other exposure/risk-based concern

Already in CoRAP
2025 2025 Slovenia

68938-03-4

Octene, hydroformylation products, low-boiling

suspected PBT/vPvB,

consumer use,

high (aggregated) tonnage

Already in CoRAP
2025 2025 France

60-29-7

Diethyl ether

suspected C,

suspected M,

suspected R,

other hazard-based concern,

wide dispersive use,

consumer use,

exposure of environment,

high (aggregated) tonnage

Already in CoRAP
2025 2025 Belgium

95235-30-6

4-(4-isopropoxyphenylsulfonyl)phenol

potential endocrine disruptor,

other exposure/risk-based concern

Already in CoRAP
2026 2025 Netherlands

149-44-0

Sodium hydroxymethanesulphinate

suspected C,

suspected M,

suspected R,

wide dispersive use,

exposure of workers,

high (aggregated) tonnage

Already in CoRAP
2026 2025 France

1333-86-4

Carbon black

C, suspected R,

wide dispersive use,

consumer use,

exposure of sensitive populations,

exposure of workers,

cumulative exposure,

high (aggregated) tonnage

Already in CoRAP
2026 2025 France

32492-61-8

4,4′-isopropylidenediphenol, ethoxylated

suspected M,

potential endocrine disruptor,

wide dispersive use,

exposure of environment,

high (aggregated) tonnage

Already in CoRAP
2026 2025 France

n.a.
(EC No. 931-700-2)

Betaines, C12-14 (even numbered)-alkyldimethyl

suspected R,

other hazard-based concern,

wide dispersive use,

consumer use,

exposure of environment,

exposure of workers,

high RCR,

high (aggregated) tonnage

Already in CoRAP
2026 2025 France n.a.
(EC No. 941-303-6)
Esterification products of 1,3- dioxo-2- benzofuran-5-carboxylic acid with nonan-1-ol suspected R, potential endocrine disruptor, suspected PBT/vPvB, consumer use, exposure of environment

already

in

CoRAP

With-drawn 2024 Germany

13674-87-8

Tris[2-chloro-1-(chloromethyl)ethyl] phosphate

potential endocrine disruptor Already in CoRAP

Next steps

  • Registrants are encouraged to verify whether their substances are on the 2024-2026 CoRAP list. Of highest importance are the first 10 entries earmarked for evaluation in 2024, since registrants of these substances will be affected the soonest.
  • ECHA recommends that companies which have registered any of the first 10 substances under REACH initiate early communication with co-registrants and the evaluating member-state competent authority (eMSCA) for details on the upcoming evaluation. Contact details for the eMSCAs are given in the final column of the list of CoRAP substances.
  • The eMSCAs assigned to the 28 listed substances now have 12 months to complete the respective evaluations. During this time, they will determine whether additional information needs to be obtained from registrants to confirm whether use of the substances poses a risk to human health or the environment. If the evaluation concludes that further information to clarify this risk is not needed and no concerns exist, the evaluation is concluded without additional information requests.
  • If the eMSCA finds that additional information is necessary to clarify the status of the CoRAP substance, affected registrants can expect to receive a draft substance evaluation decision requesting additional information after the 12-month evaluation. In these cases, registrants are given opportunity to initially comment on the requested information, which is often for data that must be generated through further testing.
  • The authorities will issue a final decision on the scope of any information requested, based on the registrant responses. This final decision will include a deadline by which the companies of the registered substances are required to submit the requested information.

Key Documents and Dates

Get an insider’s view on regulatory movements.

Sign up for AgencyIQ’s newsletters to receive exclusive regulatory updates and analysis impacting the life sciences or chemical industry.

Copy link
Powered by Social Snap